Site Deviation Investigator

About Site

Catalent’s Greendale, Indiana site is a key part of the company’s Wellness business, serving as one of North America’s primary gummy development and manufacturing centers. The site specializes in the formulation and production of traditional gelatin gummies and 100% plant‑based pectin gummies for nutritional supplements and nutraceutical applications, supporting a wide range of consumer health products. With strong in‑house R&D, quality laboratories, and flexible manufacturing and packaging capabilities, the Greendale operation partners closely with customers to develop innovative, high‑quality, and consumer‑friendly gummy delivery formats across a variety of flavors, shapes, and functional ingredients, all produced under rigorous quality and food‑safety standards.

We have an opportunity for a Site Deviation Investigator to join our team. In this role, you will be responsible for leading investigations into deviations that occur during the manufacturing process, including packaging, processing, and supporting areas. You will identify root causes, implement corrective and preventive actions, and monitor trends to prevent recurrence. This position requires working independently, collaborating with cross‑functional teams, and ensuring compliance with Good Manufacturing Practices to maintain readiness for regulatory inspections.

Shift: Monday to Friday, business hours

Location:

Greendale, IN
100% Onsite

• Gather information from internal and external sources to evaluate deviation impact on products and future operations.
• Act as liaison with inter‑departmental teams to ensure timely data collection for investigations.
• Assess historical manufacturing and laboratory data, apply root‑cause analysis tools, and design corrective and preventive actions to address quality deficiencies.
• Provide technical expertise on deviation investigation processes.
• Work independently to comply with procedure‑driven guidelines for deviation investigations and maintain deadlines.
• Lead revision or development of Standard Operating Procedures as defined in corrective and preventive actions.
• Drive continuous improvement in manufacturing operations.
• Use risk management tools to determine product quality and support material/product disposition.
• Present completed investigations to the site leadership team for concurrence.
• Keep site management updated on investigation progress.
• Perform other duties as required in support of Catalent Wellness.

• Bachelor’s degree or equivalent combination of education and experience.
• Three to five years of experience in manufacturing or related work with emphasis on current Good Manufacturing Practices, including Quality Assurance, Quality Control, Validation, Manufacturing, or process engineering.
• Proven ability to influence others outside your department.
• Proficient in English verbal and written communication skills.
• Proficient in Microsoft Office applications (Word, Excel, Track Wise, 365 Copilot).
• Knowledge of governing standards and regulations (e.g., 21 CFR Part 4, Part 11, Parts 210/211, Part 820 QSR, ISO 13485, ISO 14971, JPAL).
• Strong deductive and inductive critical thinking skills.
• Advanced technical writing skills (highly desired).
• Strong interpersonal, written, and verbal communication skills.
• Ability to interface positively with regulatory agencies, customers, and internal departments.
• Ability to lead cross‑functional teams and ensure alignment on documented findings.
• Ability to summarize technical information from Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and engineering areas to create comprehensive investigation reports.
• Basic knowledge of statistical tools and their application.
• Strong technical skills to solve complex problems.
• Ability to work effectively under pressure to meet deadlines.
• Experience working with third‑party contract manufacturing in the industry.
• Individual may be required to sit and stand for extended periods.
• Ability to enter manufacturing areas requiring full gowning, including bending, kneeling, and standing for long periods in cleanroom or warehouse areas.
• Frequent sitting, standing,…